Document Associate

United States, Walkersville (Maryland)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza Walkersville  is actively seeking a Document Control Associate. This position is responsible for performing duties in Document Control including issuance of documents as required by manufacturing, filing documents and manufacturing records, registering, controlling and releasing documents in an electronic document management system. Also responsible for audit and inspection support as needed.

Key responsibilities:

  • Assist with the administration of the Electronic Document Management System (DMS). Assist other employees on use of the DMS system.

  • Issue Device History Records and other production documents.

  • Utilize Microsoft Access databases and Excel spreadsheets inputting data used for quality tracking.

  • File Device History Records, archive documents, audit and inspection support as needed

  • Other document projects as assigned by the department manager.

  • Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.

  • Comprehend and complete necessary production paper work.

  • Interface and communicate effectively with work groups to ensure completion of tasks and projects.

Key requirements:

  • Associate’s degree preferred . High schools diploma or equivalent and experience with word processing particularly of manufacturing documentation and Standard Operating Procedures is required.

  • Computer software skills including, Microsoft Office. Other ERP and EDMS experience helpful.

  • Basic GMP and part 11 compliance knowledge is preferred.

  • Filing, organization, record keeping and planning skills; ability to manage multiple projects concurrently; time management skills is required.

  • Written and oral communication skills is required.

  • Ability to work both independently and in a team oriented environment is required.

  • Must be able to work in a fast paced environment with changing priorities is required.

  • Must be available to work overtime continually and potentially with short notice is required.

  • Ability to lift up to 20 lbs is required.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. 

Reference: R33504